WO2009117563A2 - Ballon dilatateur - Google Patents

Ballon dilatateur Download PDF

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Publication number
WO2009117563A2
WO2009117563A2 PCT/US2009/037644 US2009037644W WO2009117563A2 WO 2009117563 A2 WO2009117563 A2 WO 2009117563A2 US 2009037644 W US2009037644 W US 2009037644W WO 2009117563 A2 WO2009117563 A2 WO 2009117563A2
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
stenosis
dumbbell
support member
stent
Prior art date
Application number
PCT/US2009/037644
Other languages
English (en)
Other versions
WO2009117563A3 (fr
Inventor
Michael John Rutter
Original Assignee
Michael John Rutter
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Michael John Rutter filed Critical Michael John Rutter
Publication of WO2009117563A2 publication Critical patent/WO2009117563A2/fr
Publication of WO2009117563A3 publication Critical patent/WO2009117563A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1028—Larynx
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1032—Trachea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1035—Bronchi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

  • the present invention relates to medical care for relieving a stenosis or deploying a stent in a patient.
  • the invention relates to a balloon device for performing dilation of a lumen in a patient's larynx, trachea or bronchi, vascular system, esophagus, or other areas of the body needing such treatment.
  • Airway balloon dilation has been shown to be a safe and effective palliative procedure for treatment of mild congenital and acquired stenosis of the trachea and bronchi.
  • Dilation of luminal human anatomy to treat stenoses can be dated back to the 16 th Century with esophageal "bougie" dilation.
  • Specific medical applications of luminal balloon dilation range from alimentary canal and airway dilation to dilation of the vasculature.
  • Airway dilation dates back over 100 years ago with the invention and subsequent use of the first beveled rigid bronchoscopes for stricture management.
  • Airway balloon dilation can be used to quickly re-establish tracheal or bronchial luminal patency to restore airflow in a way that doesn't cause excessive trauma to the patient.
  • Literature has reported the use of balloon dilation for the treatment of benign strictures of the airway.
  • Fibrotic strictures such as those secondary to tuberculosis, long-term endotracheal or tracheostomy tube placement, berylliosis, Wegener's granulomatosis, or sarcoidosis have been shown to be treatable with airway balloon dilation therapy with general success. Additionally, balloon dilation has been useful in treating strictures secondary to major surgical interventions such as lung transplantation, sleeve resection, bronchial re-implantation, and lobectomy. For the purpose of treating strictures secondary to malignant obstruction, dilation therapy can be used alone or in combination with other techniques such as surgical resection, cryotherapy, laser therapy, and stent placement, depending on the desired outcome for the patient.
  • Treatment with airway dilation can involve the clinician inserting increasingly larger tubes into the airway (e.g. endotracheal tubes or cat-tail (bougie) dilators), which creates significant shear forces on the airway mucosa.
  • tubes e.g. endotracheal tubes or cat-tail (bougie) dilators
  • endotracheal tubes or cat-tail (bougie) dilators e.g. endotracheal tubes or cat-tail (bougie) dilators
  • a procedure sometimes induces unwanted trauma to the airway in the form of deep lacerations and hemoptysis.
  • current dilation practices do not permit dilation of a tracheal stenosis that is distal to a narrowing of the proximal airway (i.e. a mild subglottic stenosis).
  • angioplasty balloons are typically carried out using angioplasty balloons; however, several limitations to the use of angioplasty balloons become evident when used on the airway. For example, it may be difficult to adequately ventilate the patient during the dilation period, since the typical angioplasty balloon does not include a connection to an oxygen source. Further, the shape of the angioplasty balloon may predispose the balloon to slide out of place during dilation, or the balloon may be limited to the amount of pressure that can be applied before the balloon bursts. Also, the typical angioplasty balloon can usually stretch the airway lumen but not permanently dilate it.
  • the present invention provides a balloon dilator for use to quickly re-establish luminal patency to restore flow of air or fluids in a way that avoids excessive trauma to the patient.
  • the invention provides an apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus comprising a central axis and an inflatable outer dumbbell-shaped balloon having an external surface, the apparatus being insertable into a lumen of a patient for movement of the balloon therein between a deflated configuration and an inflated configuration.
  • Another aspect of the invention provides a method for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a lumen of a patient, the method comprising the steps of: (1) inserting an apparatus into the lumen, the apparatus comprising a central axis and an inflatable outer dumbbell-shaped balloon having an external surface, the apparatus being insertable into the lumen of a patient for movement of the balloon therein between a deflated configuration and an inflated configuration, (2) advancing the apparatus within the lumen until the dumbbell-shaped balloon is positioned within the area of the stenosis or the area in need of the stent, and (3) inflating the dumbbell-shaped balloon to cause and allow the external surface of the balloon to expand upon and dilate the area of the stenosis or the area in need of the stent.
  • Another aspect of the invention provides an apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus comprising a central axis; an inflatable dumbbell-shaped outer balloon having an external surface; at least one inflatable inner balloon; a flexible support member mounted along the central axis of the apparatus and on the external surface of the outer balloon, the flexible support member being substantially compliant with the external surface of the outer balloon during movement therewith; and at least one microsurgical blade attached to the support member and adapted to form an effective cutting edge upon inflation of the outer balloon; the apparatus being insertable into the lumen of a patient for movement of the balloons therein between a deflated configuration and an inflated configuration, the at least one inner balloon configured to inflate inside the outer balloon yet separately from the outer balloon, the dumbbell shape of the outer balloon adapted to hold the outer balloon in position over the site of the stenosis or the area in need of the stent, and the at least one blade adapted to form
  • FIG. 1 is a perspective view of one embodiment of the balloon dilator of the present invention.
  • FIG. 2 is a perspective view of one embodiment of the balloon dilator in which the outer balloon has a dumbbell shape and multiple inner balloons.
  • FIG. 3 is a perspective view of a flexible support member having microsurgical blades, the support member adapted to fit over the outer balloon according to one aspect of the invention.
  • the present invention provides an apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus comprising a central axis and an inflatable outer dumbbell-shaped balloon having an external surface, the apparatus being insertable into a lumen of a patient for movement of the balloon therein between a deflated configuration and an inflated configuration.
  • the apparatus and method are more broadly applicable for use in treating any stenosis or area in need of a stent in a patient.
  • the invention may be used for performing dilation of a lumen in a patient's larynx, trachea or bronchi, vascular system, esophagus, or other areas of the body.
  • One aspect of the invention provides an apparatus for performing an airway balloon dilation procedure at the site of a stenosis in the airway of a patient.
  • the apparatus comprises a balloon that when deflated has a narrow diameter, but inflates in a dumbbell shaped fashion whereby the proximal and distal aspects of the balloon inflate before the central aspect of the balloon. This can be achieved by providing the central half of the balloon with a greater wall thickness than the proximal and distal aspects of the balloon.
  • the advantage of this configuration is that once the balloon is employed across a stenosis and inflated, the proximal and distal ends inflate on either side of the stenosis and prevent slipping of the balloon.
  • the central aspect of the balloon then inflates, expanding the stenosis.
  • the dumbbell-shaped balloon When the dumbbell-shaped balloon is fully inflated, it typically has a substantially uniform diameter from its proximal end to its distal end.
  • This apparatus and method would also benefit placement of expandable stents, whereby a stent placed over the central aspect of the balloon would not be able to slip off the balloon once the proximal and distal aspects of the balloon are inflated, locking the stent in position over the central aspect of the balloon.
  • the present invention is particularly useful as an airway dilator, it is also useful in other areas of the body where balloon slippage is undesirable or where stent deployment is desirable.
  • Another aspect of the invention provides an apparatus for performing an airway balloon dilation procedure at the site of a stenosis in the airway of a patient, the apparatus comprising a balloon with an outer membrane and optional inner balloons that allow greater radial pressure to be applied, exceeding the rated burst pressure of similar diameter balloons, due to the inner balloons being of smaller radius when inflated than the outer balloon.
  • one embodiment of the present invention is an apparatus 10 for performing a balloon dilation procedure at the site of a stenosis in the airway of a patient, the apparatus comprising an inflatable outer balloon 12 which has an external surface 14.
  • the apparatus also comprises a central axis 16, a hollow core 18, and at least one inflatable inner balloon 20 adapted to inflate inside the outer balloon 12.
  • the apparatus 10 is typically insertable into the airway of a patient for movement of the balloons 12, 20 between a deflated configuration and an inflated configuration.
  • the inner balloon 20 is designed to inflate inside the outer balloon 12 yet separately from the outer balloon, adding the ability of the apparatus to produce high dilation pressures without balloon rupture.
  • the hollow core 18 traverses the entire apparatus 10.
  • the hollow core connects via a proximal ISO connector to an oxygen source such as an anesthesia circuit or the like, and is designed to allow the patient to be ventilated upon inflation of the balloons during the procedure, when the airway is otherwise occluded.
  • the hollow core 18 is typically in the form of a central ventilating tube which is necessarily strong to prevent the pressure of the balloons from crushing the ventilating tube.
  • the structure of the hollow core 18 is typically similar to a small endotracheal tube with a dilating cuff, and the tube may be reinforced, e.g. with wire, in the area of the cuff.
  • the balloon dilator of the present invention can have a fairly rigid (e.g. wire-reinforced) and relatively large central hollow core that can permit limited ventilation.
  • an 8.0 mm balloon dilator i.e. having an outer diameter of 8.0 mm when inflated
  • a 16mm balloon dilator can have a central ventilating core with a 4.0 mm inner diameter and a 5.5 mm outer diameter.
  • one embodiment of the invention is a balloon dilator apparatus 30 in which the inflatable outer balloon 32 is dumbbell-shaped.
  • This dumbbell shape typically is created by making the proximal 34 and distal 36 ends of the balloon with a decreased balloon wall thickness as compared to the central section 38 of the balloon, which has a relatively increased balloon wall thickness.
  • the central section 38 can have a flexible casing or layer of plastic or the like surrounding it (not shown), thereby preventing the central section 38 from dilating as quickly as the proximal and distal ends, 34, 36, yet still permitting complete inflation of the central section 38 at the higher inflation pressures.
  • the dumbbell shape can be obtained by forming the balloon from two or more different materials.
  • the proximal 34 and distal 36 ends of the balloon may be made from a more readily expandable plastic material than the central section 38 of the balloon.
  • the dumbbell shape prevents balloon slippage by inflating at either end (i.e. on either side of the stenosis) before the central section 38 inflates, and allows the central section 38 of the outer balloon 32 to stay in position over the stenosis during inflation.
  • the proximal 34 and distal 36 ends of the outer balloon 32 inflate first, forming the "dumbbell" shape, thereby trapping the stenotic airway segment at the central portion 38 of the balloon 32, so that the outer balloon 32 does not slip out of position. Then, as the pressure in the balloon is increased, the central portion 38 of the balloon fully inflates at the site of the stenosis.
  • the present invention can provide a balloon dilator with a rated burst pressure of up to 30 Atmospheres (atm).
  • the larger the balloon diameter, the lower the burst pressure e.g. for comparable Blue Max ® angioplasty balloons, a 6.0 mm balloon has a rated burst pressure of 20 atm, while a 14.0 mm balloon has a rated burst pressure of 8 atm, and a 20.0 mm balloon has a rated burst pressure of 3.1 atm.
  • the present invention provides an balloon which acts as an outer "sheath" that contains a series of inner balloons with smaller individual diameters that can tolerate a higher rated burst pressure than the outer balloon.
  • the apparatus 30 can include a plurality of inner balloons
  • inner balloon 44 is contained inside inner balloon 42, which is contained inside inner balloon 40. All of the inner balloons 40, 42, 44 are contained inside outer balloon 32, and are typically separately inflatable. Such an embodiment could be used with larger diameter outer balloons, e.g. between about 10 to about 20 mm. hi this embodiment, the inner balloons 40, 42, 44 can be either dumbbell shaped or a "double cone" shape as seen with most angioplasty type balloons, and are inflated sequentially if higher pressures cannot be achieved by the outer balloon. Having a balloon dilator that incorporates multiple interconnected smaller balloons can achieve the desired pressure without risking balloon rupture during inflation.
  • one embodiment of the invention can include a flexible support member 50 that can fit over the apparatus, specifically fitting over the outer balloon.
  • the flexible support member 50 is typically made of a polyurethane material and includes a central axis 56 mounted along the central axis of the apparatus.
  • the support member is adapted to fit over the external surface of the outer balloon, and is typically substantially compliant therewith during inflation and deflation.
  • Support member 50 also includes at least one microsurgical blade, and in FIG.
  • Blades 52 form an effective cutting edge upon inflation of the outer balloon.
  • Blades 52 are typically made of stainless steel, and are elongated and permanently mounted on the flexible support member 50. In use, when the support member 50 is placed over the outer balloon, the blade axis 54 is parallel to the central axis 56 of the support member 50, which is substantially parallel to the central axis of the apparatus.
  • Having surgical blades 52 present on the apparatus during dilation typically permits controlled cutting or lysis of any scar tissue present in the patient's airway.
  • the blades 52 should be clearly marked so that users can avoid inadvertently cutting themselves during placement of the support member 50 over the outer balloon.
  • the blades 52 lay flat on the surface of the support member prior to use and prior to inflation of the outer balloon 12, and then when the outer balloon reaches a certain pressure upon inflation the blades 52 will typically "stand up” or otherwise protrude or expose their cutting edge atop the flexible support member 50. Once fully deployed, the exposed edge of the blade 52 typically only protrudes between about 0.2 to about 0.4 mm, and the length of the blade is typically less than the length of the outer balloon 12.
  • each of the blades being separated from the other blades so that each blade is free to move from a relatively flat position to a cutting position on the flexible support member upon inflation of the outer balloon.
  • the balloon dilation procedure is typically performed at the site of a stenosis in the airway of a patient (i.e. the larynx, trachea or bronchi).
  • the surgeon or clinician first inserts the apparatus 10 into the airway, then advances the apparatus within the airway until the outer balloon 12 is across the stenosis.
  • the surgeon or clinician inflates the outer balloon 12 to cause and allow the external surface 14 of the outer balloon 12 to expand upon and dilate the stenosis.
  • the inner balloon 20 is then slowly inflated. Typically the inner balloon 20 is inflated after the inflation of the outer balloon 12.
  • the balloons are typically inflated from between about 30 to about 120 seconds.
  • the apparatus 10 can also be threaded over a guidewire (not shown) which fits through the hollow core 18 and is positioned across the stenosis. Repeat inflation-deflation cycles can be done if airway narrowing remains after the initial attempt.
  • the size of the balloon is first selected by the clinician, which depends upon the size of the stenosis in the patient's airway.
  • the balloon size is typically between about 10mm to about 40mm in length.
  • the outer balloon is positioned over the stenosis and then each balloon is individually dilated to the desired pressure with a balloon pump, typically to between about 8 to about 20 atmospheres. After these pressures are maintained for a predetermined period of time, typically between about 60 to about 180 seconds, the balloons are deflated and the clinician determines if repeat inflation is necessary. Repeat inflation can be safely performed if there is no obvious trauma to the airway.
  • the balloon dilator of the present invention typically allows ventilation while inflated
  • the balloon dilator can also be manufactured without an inner hollow core for ventilation, but simply with a small lumen large enough to pass a guidewire.
  • the advantage of such an embodiment is that the un-inflated balloon without a hollow core for ventilation is typically much "skinnier" and can pass through a very small hole (lumen) in the trachea or airway easier than a balloon dilator with a hollow core adapted to allow the patient to be ventilated therethrough.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L’invention concerne un appareil médical permettant d’élargir une sténose ou de déployer un stent chez un patient. L’appareil comprend un axe central et un ballon en forme d’haltère externe gonflable. L’appareil peut être inséré dans une lumière d’un patient pour le mouvement du ballon à l’intérieur entre une configuration dégonflée et une configuration gonflée. Le ballon reste en position sur la sténose ou la zone concernée du stent lorsqu’il est gonflé. L'appareil peut comprendre un élément de support flexible monté sur la surface externe du ballon avec au moins une lame microchirurgicale, qui forme un bord de coupe efficace lors du gonflage du ballon externe. L’appareil peut également comprendre un ou plusieurs ballons internes qui permettent d’obtenir des pressions de dilatation supérieures devant être générées depuis l’intérieur du ballon externe. L’appareil peut également comprendre un noyau central creux permettant la ventilation des voies respiratoires pendant le processus de dilatation.
PCT/US2009/037644 2008-03-21 2009-03-19 Ballon dilatateur WO2009117563A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/052,983 US7771446B2 (en) 2005-09-21 2008-03-21 Balloon dilator
US12/052,983 2008-03-21

Publications (2)

Publication Number Publication Date
WO2009117563A2 true WO2009117563A2 (fr) 2009-09-24
WO2009117563A3 WO2009117563A3 (fr) 2009-11-19

Family

ID=41091535

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/037644 WO2009117563A2 (fr) 2008-03-21 2009-03-19 Ballon dilatateur

Country Status (2)

Country Link
US (1) US7771446B2 (fr)
WO (1) WO2009117563A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10456160B2 (en) 2015-03-09 2019-10-29 Teleflex Innovations S.À.R.L. Stenotic region scoring assembly and method

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US9913964B2 (en) * 2008-12-29 2018-03-13 Acclarnet, Inc. System and method for dilating an airway stenosis
CA3028172C (fr) 2011-01-18 2020-12-22 Loma Vista Medical, Inc. Dispositifs medicaux gonflables
WO2014063039A1 (fr) 2012-10-18 2014-04-24 Loma Vista Medical, Inc. Dispositifs médicaux gonflables renforcés
LV14883B (lv) * 2013-01-18 2014-09-20 Sistēmu Inovācijas, As Dubults, griezošs balonkatetrs
US9956383B2 (en) 2013-03-15 2018-05-01 Cook Medical Technologies Llc Medical devices and methods for providing access to a bodily passage during dilation
WO2017203523A1 (fr) 2016-05-23 2017-11-30 Mor Research Applications Ltd. Dispositif d'anastomose.
US10433857B2 (en) 2016-06-24 2019-10-08 Bryan Medical, Inc. Balloon dilation catheter
US10953204B2 (en) 2017-01-09 2021-03-23 Boston Scientific Scimed, Inc. Guidewire with tactile feel
JP6975857B2 (ja) * 2018-07-09 2021-12-01 株式会社グッドマン バルーンカテーテル
US11602460B2 (en) 2020-12-15 2023-03-14 Ayal Willner Eustachian tube drug eluting stent
WO2023168123A1 (fr) * 2022-03-04 2023-09-07 Bryan Medical Inc. Cathéter de dilatation à ballonnet

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Publication number Priority date Publication date Assignee Title
US10456160B2 (en) 2015-03-09 2019-10-29 Teleflex Innovations S.À.R.L. Stenotic region scoring assembly and method

Also Published As

Publication number Publication date
US20080167608A1 (en) 2008-07-10
US7771446B2 (en) 2010-08-10
WO2009117563A3 (fr) 2009-11-19

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